CRA phase 4 studies - open for candidates with a first experience in clinical research!

For one of our clients, a known pharmaceutical company in Brussels region, we are urgently looking for a CRA for phase 4 studies.

This position is open for candidates with a first experience in clinical research (f.e. as CTA, inhouse CRA, study nurse,...)

Don't hesitate to get in touch for more information!

 

Responsibilities 
  • May support in operational feasibility to assess feasibility of trial in Belgium.
  • Nominate in close collaboration with Medical Advisor and CSM new sites for clinical trials; analyze capability and make recommendation for trial inclusion.
  • Assume ambassadorial role to facilitate communication between sites and line functions and increase value proposition to investigators.
  • Facilitate preparation and collection of site level documents; resolve problems as required.
  • Create and oversee entire site management of smaller trials, including initiation and training, monitoring and close-out visits, regulatory assessment, drug supply management and resolution of site problems to ensure compliance.
  • Track trial execution milestones;
  • Manage recruitment with support of CSM and IGH and execute contingency plans, if needed.
  • Assure preparation/generation of study visit monitoring reports.
  • Manage data at the site; resolve technical and content issues to achieve aggressive database lock targets.
  • Participate in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement.
  • May act as local and/or global “Lead CRA” and author global monitoring plan for smaller or non-complex trials.
  • May support and perform site contract negotiations (in close collaboration with CSM and/or IGH).
  • May monitor trial costs and budget (in close collaboration with CSM) and identify problems; resolve issues and escalate as appropriate.
Profile 
  • Degree in a scientific or health care discipline strongly preferred.
  • Dutch, English and French
  • Desired 1-3 years experience in clinical research or having demonstrated adequate level of proficiency within the CRA competency profile.
  • Understands and can apply knowledge of clinical trial designs to trial execution.
  • Knowledge and experience in international Standards (GCP/ICH), international (FDA,EMA) and local regulations.
  • Proven expertise in effective communication, in managing multiple priorities and in computer literacy.
Contact Information 

Hilde Wolput
hilde.wolput@valesta.com
015 21 11 04

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